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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K011179
Device Name DELDENT ULTRASONIC INSERTS
Applicant
Deldent , Ltd.
19 Keren Kayemet St.
Petach Tikvah,  IL 49372
Applicant Contact ALAN EDEL
Correspondent
Deldent , Ltd.
19 Keren Kayemet St.
Petach Tikvah,  IL 49372
Correspondent Contact ALAN EDEL
Regulation Number872.4850
Classification Product Code
ELC  
Date Received04/17/2001
Decision Date 06/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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